Company Overview - SeaStar Medical Holding Corporation has successfully treated its first patient with QUELIMMUNE™, an FDA-approved therapy for acute kidney injury (AKI) in pediatric patients [1][2] - The company aims to provide widespread access to QUELIMMUNE, which has shown potential to save lives and reduce dialysis dependency in severely ill children [2] Product Details - QUELIMMUNE is a patented cell-directed extracorporeal therapy that targets activated proinflammatory neutrophils and monocytes, restoring them to a reparative state [4] - The treatment process takes about 15 minutes and requires a full course of therapy lasting three to seven days, with the SCD-PED cartridge replaced every 24 hours [4] Clinical Impact - Approximately 4,000 children in the U.S. require continuous kidney replacement therapy annually, with a mortality rate of around 50% [2] - Clinical trials indicate that children treated with QUELIMMUNE had a 77% survival rate without dialysis dependency at 60 days, with no serious adverse events reported [2] Market Opportunity - The adult AKI population is significantly larger than the pediatric population, representing a multibillion-dollar market opportunity for SeaStar Medical [5] - The company is currently enrolling patients in the adult NEUTRALIZE-AKI pivotal clinical trial, expanding its therapeutic reach [5] Company Mission - SeaStar Medical is focused on redefining extracorporeal therapies to mitigate excessive inflammation's impact on vital organs, aiming to provide life-saving solutions for critically ill patients [6]

If you suffered a loss on your SeaStar investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at www.glancylaw.com/cases/SeaStar-Medical-Holding-Corporation/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at shareholders@glancylaw.com to learn more about your rights. On this news, SeaStar's stock price fell $0.04, or 4.8%, to close at $0.7 ...

QUELIMMUNE, or Selective Cytopheretic Device for pediatrics, represents a transformative solution for pediatric patients suffering from acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring kidney replacement therapy (KRT). Early clinical data suggest a 77% survival rate for patients treated with this new therapy1. Through Nuwellis' exclusive U.S. license and distribution agreement with SeaStar Medical (NASDAQ:ICU), the developer of QUELIMMUNE, this therapy is now ...

SAN DIEGO, July 15, 2024 (GLOBE NEWSWIRE) -- Robbins LLP reminds investors that a shareholder filed a class action on behalf of persons and entities that purchased or otherwise acquired SeaStar Medical Holding Corporation (NASDAQ: ICU, ICUCW) securities between October 31, 2022 and March 26, 2024. SeaStar was originally a special purpose acquisition company functioning under the name LMF Acquisition Opportunities, Inc. Legacy SeaStar was a medical technology company developing extracorporeal therapies to re ...

To be considered for a lead plaintiff role, a SeaStar investor must file a motion in the U.S. District Court for the District of Colorado, no later than September 6, 2024. Please contact Edelson Lechtzin LLP to discuss your investment losses, at 844-696-7492 or by e-mail at [email protected]. You can also submit your trading information online HERE. Headquartered in Denver, Colorado, SeaStar is a medical device company that develops Selective Cytopheretic Device (SCD) therapies to reduce hyperinflammation's ...

# # # DENVER, July 12, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) reports the initial commercial sale of QUELIMMUNE™-Pediatric to its U.S. license and distribution partner, Nuwellis, Inc. QUELIMMUNE is SeaStar Medical's Selective Cytopheretic DevicePediatric (SCD-PED), a patented cell-directed extracorporeal therapy that selectively targets the most highly activated neutrophils and monocytes responsible for hyperactive immune response. QUELIMMUNE is approved ...

DENVER, July 11, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) announces that it has closed its previously announced registered offering for the issuance and sale of an aggregate of 947,868 shares of its common stock at a purchase price of $10.55 per share of common stock in a registered direct offering priced at-the-market under Nasdaq rules. In addition, SeaStar Medical has issued in a concurrent private placement unregistered warrants to purchase up to 947,8 ...

What to do next: To join the ICU class action, go to https://rosenlegal.com/submit-form/?case_id=27084 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than September 6, 2024. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Attorney Advertising. Prior results d ...

SeaStar Medical is a commercial-stage medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. SeaStar Medical's novel technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The Company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a rang ...

Core Viewpoint - A class action lawsuit has been filed against SeaStar Medical Holding Corporation for allegedly making false and misleading statements regarding its business and compliance policies during the class period from October 31, 2022, to March 26, 2024 [1][7]. Company Overview - SeaStar Medical initially operated as a special purpose acquisition company (SPAC) named LMF Acquisition Opportunities, Inc. before merging with Legacy SeaStar Medical, Inc. [2][3]. - The merger was completed on October 28, 2022, resulting in the formation of SeaStar Medical Holding Corporation, which began trading on the Nasdaq under the ticker symbols "ICU" and "ICUCW" [6]. Merger and Business Prospects - The merger was announced on April 22, 2022, with an enterprise value of approximately $85 million attributed to Legacy SeaStar, which focuses on developing therapies to reduce inflammation in vital organs [4]. - Legacy SeaStar's Selective Cytopheretic Device (SCD) was highlighted for its potential in treating pediatric acute kidney injury (AKI), with plans to submit an application for FDA approval under the Humanitarian Device Exemption [4][5]. Allegations and Compliance Issues - The lawsuit alleges that SeaStar and Legacy SeaStar had deficient compliance controls related to the HDE application, leading to overstated regulatory prospects for the SCD [7][8]. - It is claimed that the company downplayed deficiencies in its financial controls and failed to properly account for certain financial instruments, which may result in the need to restate financial statements [8][10]. Stock Performance and Market Reaction - Following the announcement of the FDA's rejection of the HDE application on May 9, 2023, SeaStar's stock price fell by 39.69%, closing at $1.17 per share [9]. - On March 27, 2024, the company announced it would restate its financial statements, leading to a further decline in stock price by 4.84%, closing at approximately $0.71 per share [10].